(116 days)
No
The device description and summary of performance studies focus on the physical components and mechanical properties of a coaxial introducer set, with no mention of AI or ML technology.
No.
The device is used to introduce a guide wire or catheter into the vascular system, which is an interventional/diagnostic function rather than a direct therapeutic one.
No
This device is designed to introduce other devices (guide wires or catheters) into the vascular system, not to gather information about the patient's condition for diagnosis. Its purpose is procedural access.
No
The device description clearly outlines physical components made of high-density polyethylene, including a dilator, sheath, needle, and guidewire. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce a guide wire or catheter into the vascular system. This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device is a set of introducers, needles, and a guidewire designed for accessing blood vessels. These are instruments used for a medical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for accessing the vascular system for interventional procedures.
N/A
Intended Use / Indications for Use
The MedAmicus Coaxial Introducer is intended to be used in the exact same manner as the Boston Scientific Coaxial Introducer cleared by the FDA under K974640 and in a similar manner to introducers manufactured by MedAmicus, Inc. and cleared by the FDA under K932323. The intended use of these introducers is to introduce up to a 0.038 inch guide wire or catheter into the vascular system following a small 21 gauge needle stick.
The coaxial introducer set is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.
Product codes
74 DYB
Device Description
The proposed coaxial introducer set consists of an inner dilator within a slightly shorter outer sheath. The inner dilator is high density polyethylene and has length of approximately 4.5 inches. The outer sheath is also high density polyethylene and is approximately 3.5 inches long. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub on the inner dilator is high density polyethylene. The hub on the outer sheath is also high density polyethylene. The set may be 4F, 4.5F or 5F.
The kit contains a 21 gauge disposable aspiration and injection needle, a .018 inch diameter guidewire, and a Coaxial Introducer Set consisting of a sheath and dilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Testing of bonding strength between the inner dilator and its hub and the outer sheath and its hub was conducted on sterilized, finished devices to ensure acceptable joint integrity. Boston Scientific's coaxial dilator set was also tested to provide a basis for determining substantial equivalence for the mechanical properties of the proposed device. All samples met the required specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a handwritten string of characters, which appears to be a combination of letters and numbers. The string reads 'K990705' and is written in a bold, slightly slanted font. The characters are clearly defined, and the overall impression is that of a label or identifier.
JUN 2 . 1999
510(k) Summary
MedAmicus Coaxial Introducer
General Information
| Classification | Class II |
|---|---|
| Trade Name | MedAmicus Coaxial Introducer |
| Submitter | MedAmicus, Inc. |
| 15301 Highway 55 West | |
| Minneapolis, MN 55447 | |
| Contact | Dennis S. Madison |
| Vice President, Quality Assurance/Regulatory | |
| Affairs | |
| 612-559-2613 |
Predicate Devices
Percutaneous Introducers from MedAmicus, Inc. (K932323) Coaxial Introducers from Boston Scientific, Inc. (K974640)
Device Description Information
Intended Use
The MedAmicus Coaxial Introducer is intended to be used in the exact same manner as the Boston Scientific Coaxial Introducer cleared by the FDA under K974640 and in a similar manner to introducers manufactured by MedAmicus, Inc. and cleared by the FDA under K932323. The intended use of these introducers is to introduce up to a 0.038 inch guide wire or catheter into the vascular system following a small 21 gauge needle stick.
1
Device Description
The proposed coaxial introducer set consists of an inner dilator within a slightly shorter outer sheath. The inner dilator is high density polyethylene and has length of approximately 4.5 inches. The outer sheath is also high density polyethylene and is approximately 3.5 inches long. The inner dilator and outer sheath are radiopaque so that they are visible under fluoroscopy. The hub on the inner dilator is high density polyethylene. The hub on the outer sheath is also high density polyethylene. The set may be 4F, 4.5F or 5F.
The kit contains a 21 gauge disposable aspiration and injection needle, a .018 inch diameter guidewire, and a Coaxial Introducer Set consisting of a sheath and dilator.
Material Information
The proposed coaxial introducer set consists of a sheath and a dilator. The dilator uses the identical materials as those used in MedAmicus' legally marketed dilators. The sheath material for the proposed device is high density polyethylene identical to that used in the dilator with the exception that it has a durometer of 66 rather than 65 for increased stiffness. The material is produced by the same manufacturer. Materials for the sheath and dilator are processed using equivalent processing technologies as for the predicate device.
Biocompatability testing was conducted on MedAmicus' peelable sheath and dilator that uses identical material to that used in the Coaxial Introducer. Testing included all tests required to be conducted in FDA's modified ISO-10993 standard for the biological evaluation of medical devices. These included: acute systemic toxicity, acute intracutaneous toxicity, cytotoxicity, hemolysis, rabbit pyrogen and sensitization.
Device Performance/Product Testing
Testing of bonding strength between the inner dilator and its hub and the outer sheath and its hub was conducted on sterilized, finished devices to ensure acceptable joint integrity. Boston Scientific's coaxial dilator set was also tested to provide a basis for determining substantial equivalence for the mechanical properties of the proposed device. All samples met the required specifications.
2
Sterilization and Packaging Information
The sterilization cycle for the MedAmicus Coaxial Introducer kit is identical to the cycle for the predicate MedAmicus introducers. The ETO sterilization cycle for these products was validated using the AAMI method of three half cycles and one full cycle.
Validation tests were performed with spore strips (one million spores of Bacillus var niger) placed in sample product and sterilized at one half the regular cycle. The results showed a complete kill which proves a Sterility Assurance Level (SAL) of greater than 10-6.
The packaging materials for the MedAmicus Coaxial Introducer Kit are identical to the predicate MedAmicus product. These materials consist of a single sterile barrier using a Tyvek/Mylar pouch.
Substantial Equivalence
The MedAmicus Coaxial Introducer is intended to introduce up to a 0.038 inch guide wire or catheter into the vascular system following a small 21 gauge needle stick. The basic design, methods of manufacturing, and materials used are similar to existing MedAmicus introducer kits and Boston Scientific Coaxial introducers cleared by the FDA. Our application of these devices is substantially equivalent to the aforementioned standard medical procedures already approved for use. The clinical indications for use remain unchanged. MedAmicus believes the MedAmicus Coaxial Introducer is substantially equivalent to currently marketed medical introducer devices employing the same technology.
Conclusion
In conclusion, MedAmicus believes the MedAmicus Coaxial Introducer is substantially equivalent to the predicate MedAmicus and Boston Scientific introducer sets. The intended use, materials, labeling, method of operation and manufacturing methods are substantially equivalent.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
: 必
JUN 28 1999
Mr. Dennis S. Madison Medamicus Corporation 15301 Highway 55 West 55447 Minneapolis, MN
K990705 Re: Coaxial Introducer Regulatory Class: II (two) Product Code: 74 DYB Dated: May 5, 1999 Received: June 3, 1999
Dear Mr. Madison:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Dennis S. Madison
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
S10(k) Number (if known): K 990 705
I NTRODUCER Device Name:
Indications for Use
The coaxial introducer set is indicated for use to introduce up to a 0.038 inch guide wire or catheter into the vascular systems following a small 21 gauge needle stick.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chito
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number __
(Optional Format 3-10-98)
For Prescription USE ONLY